Among analysed biochemical parameters were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CRE\]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.

Among analysed haematological parameters were eosinophils \[EOS\], haemoglobin \[Hgb\], leukocytes (white blood cells) \[WBC\], lymphocytes \[LYM\], neutrophils \[NEU\] and platelets \[PLT\]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.

Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.

Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 \[G0\], grade 1 \[G1\] (mild), grade 2 \[G2\] (moderate), grade 3 \[G3\] (severe) and grade 4 \[G4\] (potentially life threatening), as compared to baseline at Day 0.

Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above \[≥\] 37.5 degrees Celsius \[°C\] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.